Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459992
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2007-04-12
Brief Title:
Effects of Betahistine Hydrochloride in Overweight Women
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study of the Metabolic Effects of Betahistine Hydrochloride in Overweight Women
Status:
COMPLETED
Status Verified Date:
2014-12-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effects of a drug called betahistine on appetite and food intake in overweight women Betahistine has been used for many years to treat vertigo dizziness It was taken off the market in the United States in 1970 because it was thought to be ineffective for vertigo but is still used for this purpose in many other countries Some research suggests that betahistine may reduce appetite and food intake
Healthy overweight women between 18 and 50 years of age may be eligible for this study Candidates must have a body mass index BMI between 30 and 40 and weigh less than 300 pounds They are screened with a medical history and physical examination blood and urine tests electrocardiogram EKG breathing test and eating behavior questionnaires
Participants are admitted to the NIH Clinical Center for a 3-day2-night stay for the following procedures
Medication Subjects take either betahistine in one of three possible doses or placebo capsules one time on the days of admission to the Clinical Center day 1 three times on day 2 and two times on day 3
Blood tests and 24-hour urine collection
Resting metabolic rate Subjects rest quietly for 1 hour after awakening and then rest again under a clear plastic hood or while wearing a face mask breathing normally for about 25 minutes
DEXA scan to measure body fat muscle and bone mineral content Subjects lie on a table above a source of X-rays while a very small dose of X-rays is passed through the body
Meal studies Subjects food intake is measured on days 2 and 3
Questionnaires Subjects complete questionnaires about how hungry or full they are feeling and rate how much they liked the foods they ate
Healthy overweight women between 18 and 50 years of age may be eligible for this study Candidates must have a body mass index BMI between 30 and 40 and weigh less than 300 pounds They are screened with a medical history and physical examination blood and urine tests electrocardiogram EKG breathing test and eating behavior questionnaires
Participants are admitted to the NIH Clinical Center for a 3-day2-night stay for the following procedures
Medication Subjects take either betahistine in one of three possible doses or placebo capsules one time on the days of admission to the Clinical Center day 1 three times on day 2 and two times on day 3
Blood tests and 24-hour urine collection
Resting metabolic rate Subjects rest quietly for 1 hour after awakening and then rest again under a clear plastic hood or while wearing a face mask breathing normally for about 25 minutes
DEXA scan to measure body fat muscle and bone mineral content Subjects lie on a table above a source of X-rays while a very small dose of X-rays is passed through the body
Meal studies Subjects food intake is measured on days 2 and 3
Questionnaires Subjects complete questionnaires about how hungry or full they are feeling and rate how much they liked the foods they ate
Detailed Description:
Current medications for the long-term treatment of obesity are moderately effective at best Therefore research focusing on compounds that affect energy balance through novel mechanisms is warranted Preliminary human and animal data suggest central nervous system histaminergic tone is important in the regulation of food intake We therefore propose to study the effects of betahistine hydrochloride a histamine analogue which has agonist activity at the histaminergic H1 receptor and antagonistreverse agonist activity at the H3 receptor Prior animal studies have suggested that betahistine suppresses food intake and reduces body weight but there are sparse human data assessing the effects of betahistine on metabolism
Betahistine s effects on women s food intake and metabolism will be evaluated through an inpatient randomized double-blind placebo controlled dose-ranging study We will examine the acute effects of betahistine on food intake hunger and satiety resting energy expenditure and on hormones and substrates relevant for body weight regulation If results suggest betahistine has salutary effects on food intake or metabolism in humans these studies will lay the groundwork for additional investigations to assess the efficacy of betahistine in the treatment of obesity
Betahistine s effects on women s food intake and metabolism will be evaluated through an inpatient randomized double-blind placebo controlled dose-ranging study We will examine the acute effects of betahistine on food intake hunger and satiety resting energy expenditure and on hormones and substrates relevant for body weight regulation If results suggest betahistine has salutary effects on food intake or metabolism in humans these studies will lay the groundwork for additional investigations to assess the efficacy of betahistine in the treatment of obesity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-CH-0126 | None | None | None |